Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

August 16, 2025 updated by: Chen Linlin, Chinese Academy of Medical Sciences, Fuwai Hospital

The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is:

Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol.

This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Most patients with atrial fibrillation (AF) continue to experience AF following cardiac surgery, which is not conducive to postoperative circulatory stability. Intraoperative active cardioversion has rarely studied due to uncertainty regarding the efficacy of pharmacological cardioversion and the recurrence rate of AF in patients with persistent AF.

Objective: To assess the effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF.

Methods: This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with AF who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study. These patients undergoing pharmacological cardioversion during surgery were matched with untreated patients in a 1:1 ratio based on age, sex, weight, diagnosis, beta blocker and digoxin usage, indicators from cardiac ultrasound and blood gas analysis. The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. The choice between these drugs depends on the patient's blood pressure and heart rate. The incidence of cardioversion in patients who underwent the tetralogy of medication regimen approach was compared with that of untreated patients.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518058
        • Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillationwho were scheduled for elective cardiac surgery under general anesthesia

Description

Inclusion Criteria:

  • ASA Ⅱ-Ⅲ,
  • Aged 18-70 years,
  • Who were scheduled for elective cardiac surgery under general anesthesia,
  • Who were diagnosed with atrial fibrillation by preoperative 12-lead electrocardiogram or 24-hour holter electrocardiogram.

Exclusion Criteria:

  • Allergic to iodine, amiodarone or its excipients
  • Pulmonary fibrosis
  • Keratopathy or severe loss of vision or blindness
  • Patients with sick sinus syndrome, severe bradycardia (heart rate <50bpm), second- or higher-degree atrioventricular block
  • Preoperative intravenous infusion of amiodarone
  • Intraoperative radiofrequency ablation of atrial fibrillation
  • The patient is participating in another interventional clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TMR group
The treatment regimen for the tetralogy of medication regimen group (TMR group）commences with the administration of amiodarone during rewarming. In the event of cardiac relapse, a combination of the following drugs may be utilized: aminophylline, ephedrine, and isoproterenol. The selection of these medications is contingent upon the patient's blood pressure and heart rate.
Drug: The tetralogy of medication regimen

During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating：

  1. If the heart rate is ≥70 beats per minute without specific therapy and in sinus rhythm or atrioventricular junctional rhythm, no special treatment is required. If the heart rate <70 beats/min, intravenous injection of isoproterenol 2 ug may be administered.
  2. In cases where there is sinus rhythm or atrioventricular junctional rhythm with a heart rate <70 beats/min and perfusion pressure <60mmHg, intravenous injection of ephedrine 10 mg + aminophylline 0.15 g should be given.
  3. For patients with atrioventricular junctional rhythm or sinus rhythm and a heart rate <70 beats/min but perfusion pressure ≥60mmHg, intravenous injections of aminophylline (0.15g) and ephedrine (10 mg) .
  4. In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.
Other Names:
  • amiodarone
  • isoproterenol
  • ephedrine
  • aminophylline
Control group
Patients in the control group did not receive treatment with antiarrhythmic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus rhythm
Time Frame: From the release of the aortic cross-clamp until 12 hours after surgery
Electrocardiogram monitoring
From the release of the aortic cross-clamp until 12 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: From the release of the aortic cross-clamp until the end of surgery
Invasive arterial blood pressure test
From the release of the aortic cross-clamp until the end of surgery
the use of temporary pacemakers
Time Frame: From the release of the aortic cross-clamp until 12 hours after surgery
Postoperative record
From the release of the aortic cross-clamp until 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: linlin chen, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 16, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP2023036（01）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The analytical data from this study was shared upon the completion of the research. Individuals who wish to access the data are required to declare their intended use for it. Contact information for the person responsible for managing the data can be obtained from the ClinicalTrials.gov PRS website.

IPD Sharing Time Frame

The data will be made available after the study, with no deadline.

IPD Sharing Access Criteria

Visitors must obtain permission from the study leader and declare the purpose of their data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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